Unique device identifier (udi): (b)(4).The cusa handpiece was not returned for evaluation; therefore, an evaluation of the device could not be performed.Manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.Based on the customer reported failure ¿amplitude error¿ its possible this complaint was as a result of transducer delamination.However, without testing it is not possible to verify.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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